Slicing, dicing, shredding or peeling produce is processing, so a fresh-cut plant falls under 21 CFR 117, the preventive controls rule, not the Produce Safety Rule in 21 CFR 112, unless exempt. FDA issued final guidance for these plants in August 2026, replacing its 2008 guide and 2018 draft.
This guide is for food safety managers at fresh-cut plants selling in the US, their growers, and Gulf producers with US buyers.
What does FDA's final fresh-cut guidance say?
The Guide to Minimize Biological Hazards in Ready-to-Eat Fresh-Cut Produce is dated August 2026 and marked final. Its notice ran in the Federal Register on 12 August 2026 (91 FR 52011). Like all FDA guidance it is nonbinding, so "should" means recommended.
It covers ready-to-eat fresh-cut produce with water activity above 0.85, made by processors under Part 117, including farm mixed-type facilities. It is not intended for farms and deals with biological hazards only. Fresh-cut means cut, peeled, shredded or spiralized from the whole state, washed or not, with no blanching, freezing, cooking or packing in syrup or dressing.
Cutting breaks the natural barrier of the produce and releases fluids in which pathogens can survive or grow. FDA recommends that the hazard analysis evaluate Salmonella, L. monocytogenes and pathogenic E. coli. It treats Cyclospora as a potential hazard in berries, fresh basil, fresh cilantro and salad mixes.
Its longest section is on antimicrobial wash water. If you also run Codex HACCP, see our Codex HACCP guide.
Is a fresh-cut operation a farm or a food facility?
It depends on the activity. Under 21 CFR 1.227, harvesting includes field coring, trimming outer leaves, cooling and washing produce grown on a farm. Slicing is the rule's own example of extra processing that takes an operation outside the farm definition. Part 112 does not cover produce that is not a raw agricultural commodity (RAC), and FDA calls fresh-cut produce "a processed food".
| Activity | Rule that applies | Condition or basis |
|---|---|---|
| Growing and harvesting covered produce, including field coring and washing whole produce | Part 112 | Covered farm: over $34,324 average produce sales a year (FDA, 2023 to 2025) |
| Packing and holding whole produce | Part 112 on a farm. An off-farm packinghouse may be a registered facility under Part 117 | Whether the growers own most of the packinghouse |
| Slicing, dicing, shredding, peeling or spiralizing | Register with FDA. Part 117 CGMPs plus Subparts C and G | A qualified facility still registers but follows 117.201 instead of Subparts C and G |
| Cutting acid fruit below pH 4.2, such as limes, at a small or very small farm mixed-type facility | Exempt from Subparts C and G. CGMPs apply | 117.5(h)(3)(ii), only if all its Part 117 processing is on the low-risk list |
| Cutting other produce at a farm mixed-type facility | No on-farm low-risk exemption | Fresh-cut produce is excluded as a time and temperature control food (117.5(g)(2)(ii)) |
| A shop or restaurant cutting fruit for its own customers | Not registered. State or local Food Code rules | Retail food establishment or restaurant (1.226) |
| Fresh-cut produce not on the rarely-consumed-raw list | Also FSMA 204 transformation records | Not enforced before 20 July 2028 |
Some online summaries say every business that cuts produce must register and run Part 117 in full. That overstates it, because shops and restaurants do not register.
FDA calls the qualified facility exemption "the exception that is most relevant" to fresh-cut production. Qualified facilities follow the modified requirements in 117.201 instead of Subparts C and G. The very small business cut-off is $1,372,952 a year, averaged over 2023 to 2025.
Part 117 is a legal duty. Certification to a scheme such as BRCGS Food Safety is a separate, voluntary step.
Traceability sits on top. FDA's Food Traceability List names fresh-cut leafy greens, fruits and vegetables. Cutting is a "transformation", so each new lot needs records linking input lot codes and quantities to a new traceability lot code (1.1350(a)).
Congress directed FDA not to enforce the rule before 20 July 2028. FDA's rule moving the date was still only a proposal when this guide was checked.
What does FDA expect for wash water?
FDA recommends a process control that adds an antimicrobial to wash water. Its job is to stop pathogens moving from contaminated to clean produce. It is not a kill step. Organic load builds up in recirculated water and uses up the antimicrobial, so validation covers the commodity, target microorganism, critical limits, worst-case organic load, and monitoring location and frequency.
In one worked example, a chilled romaine flume doses sodium hypochlorite automatically at an operating limit set inside the critical limit, and the line stops below the critical limit. In another, peracetic acid for onions is titrated every 30 minutes. Both drain and replace flume water every 8 hours of operation or daily, whichever comes first. These are illustrations, not limits.
Records must show the actual value: "22 ppm" free chlorine, not "> 20 ppm", "OK" or "Pass". That figure is FDA's record-keeping example, not a target. Records are made at the time and must be indelible, with no correction fluid (117.305).
Why is a wash step not a Listeria control?
On 10 January 2022 FDA sent a warning letter to Onofrio's Fresh Cut in New Haven, Connecticut. Its hazard analysis had decided no preventive control was needed at cutting because of CGMPs, sanitation procedures and "a prior wash step". FDA disagreed. The produce is exposed during cutting with no lethal treatment, so environmental pathogens need sanitation controls (117.135(c)(3)).
Four of 71 FDA swabs were positive for L. monocytogenes, including a floor drain by the celery cutting table and a cart wheel. FDA had also found the organism there in 2019. Whole genome sequencing showed four unique strains across 2019 and 2021.
The final guidance agrees. L. monocytogenes can establish harbourage, especially in wet processing areas, and grows slowly under refrigeration. Sanitation controls are verified by environmental monitoring, and FDA still points to its January 2017 draft Listeria guidance for detail. Hand washing can become a sanitation preventive control, with monitoring and records, where lapses show it is needed.
What do you need from your supplier farms?
A fresh-cut processor under Subparts C and G is a receiving facility, and its suppliers are usually the growing farms. FDA says a supply-chain program for pathogens should cover fresh-cut produce not on the rarely-consumed-raw list. Where the supplier controls a hazard that could cause serious harm or death, the default is an onsite audit before first use and at least annually (117.430).
One of the guidance's four examples is cubed melon from a US distribution centre importing from three foreign covered farms. In the 2023 Salmonella outbreak linked to cantaloupe, 407 people fell ill and 6 died. Recalls covered whole melons labelled "Product of Mexico" and pre-cut products made from them.
Your growers' water duties changed too. The pre-harvest agricultural water rule of 6 May 2024 replaced microbial testing criteria with a yearly agricultural water assessment. Large farms had to comply by 7 April 2025 and small farms by 6 April 2026. Very small farms follow on 5 April 2027.
Which of these rules reach a Gulf grower or fresh-cut plant?
Part 112 covers produce RACs offered for import into the US, so a Gulf farm shipping cucumbers, peppers or herbs can fall within it. The US importer's Foreign Supplier Verification Program (FSVP) must verify that the farm gives protection equivalent to the produce safety standards.
A Gulf fresh-cut plant is a foreign facility. It registers through a US agent, renews every even-numbered year between 1 October and 31 December, and follows Part 117. The traceability rule applies to persons who manufacture, process, pack or hold listed foods.
Dates are a special case. They are on the rarely-consumed-raw list in 112.2(a)(1), so Part 112 does not cover them and fresh-cut dates are exempt from the traceability rule. The guidance adds that a processor who knows a listed item is in fact eaten without a kill step would generally need a supply-chain program for pathogens.
For GSO and Codex grading rules, see our guide to international produce guidelines.
How AGS can help
The U.S. Fresh-Cut Produce Food Safety Management System (21 CFR 117 & 112) has 244 documents in editable Word and Excel, with a compliance matrix. It includes Part 117 and Part 112 applicability assessments, a wash water management program, an antimicrobial intervention program, a Listeria control program and four HACCP models: leafy greens, melon, onion and salad kit. It contains no FSVP documents or FSMA 204 traceability plan.
Frequently asked questions
Do fresh-cut plants need allergen controls?
FDA says no fresh-cut commodity in scope is a major food allergen. A dressing packed with the produce may still need allergen controls.
Does the traceability rule cover cut fruit made from frozen produce?
No. "Fresh-cut" on the Food Traceability List excludes previously frozen forms.
Is C. botulinum a hazard in fresh-cut produce?
FDA calls it principally a concern for produce in reduced oxygen packaging.
Are time and temperature controls a CGMP or a preventive control?
Your hazard analysis decides. FDA says 117.206 can serve as a reference for managing refrigerated storage.
AGS provides independent documentation toolkits. This guide and the referenced kit are not affiliated with, endorsed by or approved by the US Food and Drug Administration. It is general information, not legal advice. Which rule applies depends on your operation, its sales and its activities.
Reviewed October 2026. Facts checked against the sources current at publication.
